Job Description
📋 Description Lead device and combination product development within Injection Device Development in Operations. Provide technical leadership for design, regulatory readiness, and lifecycle management of devices. Drive cross-functional collaboration across operations, R&D, quality, regulatory, and Translate technical strategy into executable plans and milestones. Evaluate emerging technologies and regulatory trends; translate insights into action. Mentor technical colleagues and present study results to varied audiences. 🎯 Requirements Bachelor’s degree in Mechanical Engineering or related field with 16 years of experience; Master’s Experience leading device or combination product development in a regulated environment. Knowledge of design controls (21 CFR 820 / ISO 13485 Design Controls), risk management Strong ability to turn technical strategy into executable plans; track record of product launches Excellent collaboration and communication; experience mentoring others and influencing without Working knowledge of regulatory expectations and industry standards; ability to manage multiple 🎁 Benefits Comprehensive benefits package including PTO, medical/dental/vision, and 401(k). Eligible for long-term incentive programs.
